Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial … (NCT05104099) | Clinical Trial Compass
CompletedPhase 2
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
France17 participantsStarted 2021-11-29
Plain-language summary
This study is a single-center propsective clinical trial to assess the ability of fluorescence techniques to mark high-grade vulvar intraepithelial neoplasias including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias following 3 hours Metvixia application.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient aged 18 and over,
* With isolated high-grade vulvar intraepithelial neoplasia OR associated with invasive cancer proven histologically by biopsy
* Naive of any vulvovaginal treatment (surgery or radiotherapy)
* No metastases
* WHO \<or equal to 3
* Contraception method for women of childbearing potential
* Patient affiliated to the social security scheme
* Patient who understood, signed and dated the information note and the
* consent form,
* Patient able and willing to follow all study procedures in accordance with the protocol.
Exclusion Criteria:
* History of hypersensitivity to the active substance methyl aminolevulinate or to any of the components of the drug (including peanut oil and refined almond oil), soybean or peanut
* Ulceration or hyperpigmented lesions of the vulva
* Patient with porphyria
* Any previous vulvovaginal treatment (surgery or radiotherapy)
* Metastatic disease
* Patient undergoing treatment for any other invasive cancer
* Pregnant, likely to be or breastfeeding patient
* Patient deprived of liberty or under guardianship (including guardianship)
* Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons.
* Patient already included in another therapeutic trial with an experimental molecule,
* Associated pathology that may prevent the patient from receiving METVIXIA application and light exposure.
What they're measuring
1
Evaluation of the success of the photodynamic diagnosis
Timeframe: 14 days (+/- 4 days) after the photodiagnosis